The Effect of Physical Activity on Bone Mineralization and Immune System in Very Low Birth Weight Infants
Primary Purpose
Osteopenia of Prematurity
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
passive physical activity
Sponsored by
About this trial
This is an interventional prevention trial for Osteopenia of Prematurity focused on measuring osteopenia, very low birthweight infants, bone speed of sound, quantitative ultrasound
Eligibility Criteria
Inclusion Criteria:
- Birth weight<1500gr, appropriate for gestational age.
- After initial cardio-respiratory stabilization
- < 14 days postnatal age
- Written parental informed consent
Exclusion Criteria:
- Intrauterine growth retardation
- Severe central nervous system disorder (including IVH grade 3-4).
- Congenital anomalies/chromosomal abnormalities.
- Congenital bone disease.
Sites / Locations
- Meir Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
No Intervention
Arm Label
physical activity once a day
physical activity twice a day
control
Arm Description
Outcomes
Primary Outcome Measures
Bone Speed of sound
Secondary Outcome Measures
Anthropometric measurements
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01042639
Brief Title
The Effect of Physical Activity on Bone Mineralization and Immune System in Very Low Birth Weight Infants
Official Title
The Effect of Physical Activity on Bone Strength and Immune System in Very Low Birth Weight Infants: is More Really Better??
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
June 2012 (Anticipated)
Study Completion Date
September 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meir Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Studies have demonstrated that brief (5-10 min a day) passive range-of-motion exercise is beneficial for bone development in very low birth weight (VLBW) preterm infants. However, the optimal duration and frequency of exercise for bone development in preterm infants is yet unknown.
The effect of exercise on the immune system was widely studied in adult and children. Exercise induces increase in IL-6, IL-10, and IL1ra. In adult even 10 minutes of flexion and extension of the wrist cause systemic increase in IL-6. The effect of physical activity on pro and anti inflammatory cytokines in preterm infant was not studied.
Objectives:
To assess weather twice daily exercise intervention will enhance bone strength compared to once a day intervention
To evaluate the effect of a single exercise intervention on inflammatory mediators.
Methods:
Single center (Meir Medical Center), double blind, randomized control study.
Detailed Description
Infants will be randomly assigned to one of 3 study groups. Group 1 - physical activity once a day. Group 2 - physical activity twice a day and group 3 - control.
The physical activity program is based on the Moyer-Mileur et al protocol (1). Briefly, this protocol involves extension and flexion range-of-motion exercise against passive resistance of both the upper and lower extremities. Both extension and flexion were performed five times at the wrist, elbow, shoulder, ankle, knee, and hip joints (about 10 minutes for each session). Infant in group 1 have the physical activity intervention once a day, 5 days a week. Infant in group 2 will have the same physical activity intervention twice a day, five times a week. Infant in group 3, the control group will have a similar time (10 minutes) of daily interactive periods of holding and stroking without range-of-motion activity.
The physical activity will be done by the same person (the NICU physiotherapist) Growth parameters, and bone strength, will be measured at enrollment and every 2 weeks till discharge.
Bone strength assessment will be determined by quantitative ultrasound measurement of bone speed of sound (SOS) at the middle left tibial shaft (Sunlight Omnisense Premier). All measurements will be performed by the same person, who will be blinded to the group assignment.
Cytokines study In a sub-group of patients who will have arterial line at enrollment blood sample ( 0.6 CC) will be drawn before and immediately following activity for assessment of proinflammatory (IL-6) and anti-inflammatory ( IL1-ra) cytokines. Samples will be kept at -20º C and will be analyzed after completion of the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteopenia of Prematurity
Keywords
osteopenia, very low birthweight infants, bone speed of sound, quantitative ultrasound
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
physical activity once a day
Arm Type
Active Comparator
Arm Title
physical activity twice a day
Arm Type
Experimental
Arm Title
control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
passive physical activity
Other Intervention Name(s)
passive range-of-motion exercise against passive resistance.
Intervention Description
extension and flexion range-of-motion exercise against passive resistance of both the upper and lower extremities. Both extension and flexion were performed five times at the wrist, elbow, shoulder, ankle, knee, and hip joints
Primary Outcome Measure Information:
Title
Bone Speed of sound
Time Frame
during hospitalization
Secondary Outcome Measure Information:
Title
Anthropometric measurements
Time Frame
During hospitalization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Days
Maximum Age & Unit of Time
14 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Birth weight<1500gr, appropriate for gestational age.
After initial cardio-respiratory stabilization
< 14 days postnatal age
Written parental informed consent
Exclusion Criteria:
Intrauterine growth retardation
Severe central nervous system disorder (including IVH grade 3-4).
Congenital anomalies/chromosomal abnormalities.
Congenital bone disease.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ita Litmanovitz, MD
Phone
+972-9-7471554
Email
litmani@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ita Litmanovitz, MD
Organizational Affiliation
Meir Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Meir Medical Center
City
Kfar Saba
ZIP/Postal Code
44281
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ita Litmanovitz, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
7562289
Citation
Moyer-Mileur L, Luetkemeier M, Boomer L, Chan GM. Effect of physical activity on bone mineralization in premature infants. J Pediatr. 1995 Oct;127(4):620-5. doi: 10.1016/s0022-3476(95)70127-3.
Results Reference
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The Effect of Physical Activity on Bone Mineralization and Immune System in Very Low Birth Weight Infants
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